March 2014 FDA Recall Drug by Apotex Inc.
D-1299-2014 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Apotex Inc. on March 20, 2014 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1299-2014

Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Initiated
03-20-2014
Reported
05-07-2014
Quantity
11,422 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67985
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-23-2014
Product Description About Product Description
Full technical description of the product.
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.

Batch or Lot Expiration Information

Lot# : KD4855, Exp 06/14